UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049154 |
|---|---|
| Receipt number | R000055968 |
| Scientific Title | Investigation of lipid profile in the general population with no history of cardiovascular disease |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2022/10/07 16:00:08 |
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Basic information
Public title
Investigation of lipid profile in the general population with no history of cardiovascular disease
Acronym
Investigation of lipid profile in the general population with no history of cardiovascular disease
Scientific Title
Investigation of lipid profile in the general population with no history of cardiovascular disease
Scientific Title:Acronym
Investigation of lipid profile in the general population with no history of cardiovascular disease
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of cardiovascular risk factors in the current general population
Basic objectives2
Others
Basic objectives -Others
Comparison with cardiovascular risk factors in a population with heart disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglycerides
total cholesterol
HDL/LDL cholesterol
fatty acid quadrants including EPA/AA ratio
Lp(a)
HbA1c
high sensitivity CRP
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old who have undergone our physical examination and have no history of cardiovascular disease (myocardial infarction, angina pectoris, cerebral infarction, aortic dissection, aortic aneurysm, lower extremity artery occlusion).
Key exclusion criteria
History of cardiovascular disease
Taking medications or supplements containing EPA/ DHA
Persons who are deemed by their physician to be inappropriate to participate in the program
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Doi |
| Middle name | |
| Last name | Masayuki |
Organization
Kagawa Prefectural Central Hospital
Division name
Cardiology
Zip code
760-8557
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL
087-811-3333
mdoimd@gmail.com
Public contact
Name of contact person
| 1st name | Takagi |
| Middle name | |
| Last name | Wataru |
Organization
Kagawa Prefectural Central Hospital
Division name
Cardiology
Zip code
760-8557
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL
087-811-3333
Homepage URL
t_wataru1206@yahoo.co.jp
Sponsor or person
Institute
Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Prefectural Central Hospital
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
Tel
087-811-3333
chuobyoin@pref.kagawa.lg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serum EPA/AA ratio is associated with cardiovascular diseases such as angina pectoris and myocardial infarction, and a decrease in serum EPA/AA ratio has been reported as a risk factor for cardiovascular diseases.
In the general population, a decrease in serum EPA/AA ratio is presumed to be caused by a decrease in seafood intake among Japanese, but there have been few reports since then, although the Hisayama study published in 2005 can be confirmed.
We will measure the current serum EPA/AA ratio and compare it with previous results and data from patients with a history of cardiovascular disease.
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055968
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
